Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study (RIAL-COLECTOMY)
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|ClinicalTrials.gov Identifier: NCT04456933|
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 17, 2020
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage.
BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible.
Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis.
METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.
|Condition or disease||Intervention/treatment|
|Colon Cancer||Procedure: Extracorporeal left hemicolectomy anastomosis Procedure: Intracorporeal left hemicolectomy anastomosis|
HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise of the anastomosis, a smaller incision size and being able to choose its location.
The objective of this study is to demonstrate that colorectal mechanical end-to-end intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic dehiscence.
- To demonstrate the reproducibility of the colorectal mechanical end-to-end intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence, organo-cavitary infection, and other postoperative complications.
- To determine the benefits that the IC anastomosis technique can bring to patients with obesity.
- To determine the benefits that the IC anastomosis technique can provide in terms of postoperative complications, hospital stay, and size of the accessory incision.
- To determine the benefit of the application of indocyanine green to determine the point of resection and anastomosis.
Comparative, single-center, controlled non-inferiority cohort study of resection and mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic surgery (retrospective cohort).
SUBJECTS OF THE STUDY
In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.
In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.
|Study Type :||Observational|
|Estimated Enrollment :||148 participants|
|Official Title:||RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY|
|Actual Study Start Date :||June 29, 2020|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||February 28, 2022|
- Procedure: Extracorporeal left hemicolectomy anastomosis
Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years.
After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®
- Procedure: Intracorporeal left hemicolectomy anastomosis
o Intracorporeal resection of the left mesocolon
The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm)
o Preparation of Intracorporeal Anastomosis
The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®.
The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made.
Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed.
The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)
- Percentage of anastomotic leak (AL) [ Time Frame: 30 days ]Percentage of anastomic leak (defined in accordance with Peel et al.).
- Rate of global morbidity [ Time Frame: 30 days ]Dindo-Clavien Classification
- Rate of Surgical site infection [ Time Frame: 30 days ]SSI in accordance with the Center for Disease Control (CDC) National
- Rate of Re-interventions [ Time Frame: 30 days ]Percentage of re-interventions due to surgical complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456933
|Contact: Xavier Serra-Aracil, MD,PhD||34-93-723-1010 ext firstname.lastname@example.org|
|Hospital Universitario Parc Tauli de Sabadel||Recruiting|
|Sabadell, Barceelona, Spain, 08208|
|Contact: Xavier Serra-Aracil, MD,PhD 937 231 010 ext 21490 email@example.com|
|Principal Investigator:||Xavier Serra-Aracil, MD,PhD||Corporacio Parc Tauli. Parc Tauli University Hospital|